Portugal: necessary arbitration regime to resolve disputes related to reference and generic medicines

Litigation concerning reference and generic medicines has been highly debated in Portugal for the past decade. In 2011, Portugal implemented an innovative and necessary arbitration regime to resolve disputes related to reference and generic medicines as a response to the ineffectiveness of judicial and administrative courts, which were not able to deliver decisions within a reasonable period of time, and with the aim of accelerating the entry of generics in the market. Despite it being undisputed that this new legal framework has brought several advantages in reducing the administrative and legal hurdles encountered in the past, thereby enabling hundreds of cases (and a significant number of preliminary injunctions) to be heard and decided within reasonable timeframes, this regime has been subject to several critiques from courts and scholars. This demonstrates that the solution found by the Portuguese legislator is far from being consensual.